Status:
COMPLETED
Study of Combined Therapy of Aspirin and "IVIG-SN" in Kawasaki Disease
Lead Sponsor:
Green Cross Corporation
Conditions:
Kawasaki Disease
Eligibility:
All Genders
6-5 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the safety, efficacy and of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with kawasaki diseases.
Detailed Description
This clinical trial was designed as a multicenter, single-arm, and open-label clinical trial. Evaluate the incidence of coronary artery lesions in the 7th week of IVIG-SN administration, compared to ...
Eligibility Criteria
Inclusion
- Pediatric patients aged 6 months - 5 years
- Case definition for complete KD: Fever (≥ 38.5°C) for ≥ 5 days (but less than 10 days), 4/5 standard clinical criteria
- Case definition for incomplete KD: Fever ≥ 5 days(but less than 10 days) and 3 clinical criteria plus coronary artery lesion on echocardiogram.
- Subjects whose parents or legally acceptable representative (LAR) gave voluntary written consent to participate in this clinical trial
Exclusion
- Those whose blood test results show abnormalities of significance as follows : Platelet count \< 100,000/mm3, WBC count \<3,000 cells/mm3,Those whose hemogloblin, hematocrit or red blood cell count exceed 30% of the upper limit of the normal range or are 30% below the lower limit of the normal range.
- Those who have been administered other clinical product in the last 30 days after this clinical trial commenced
- Those who have been administered TNF alpha or steroid within 48 hours after being administered the test product
- Those who plan to be inoculated with live vaccine during the clincial trial period
- Those considered difficult to participate in clinical trial due to serious chronic diseases(e.g., cardiovascular diseases except controllable hypertension, diseases of the respiratory system concurrent with respiratory failure, metabolic disease, kidney dysfunction, hemoglobinopathy, etc.)
- Those who have been administered an immunosuppressant or immune modifying drug in the last 3 months before the innoculation with the test product
- Those who are HIV-positive or have immune dysfunctions including immunodeficiency
- Those who have previously exhibited hypersensitivity or shock to IVIG agents
- Patients with underlying liver disease or liver dysfunction with known etiology.
- Patients with kidney dysfunction, whose Creatinine level is found to be over 2 times higher than the upper limit of the normal ranges in a screening test
- Those who have -- or previously had -- a malignant tumor
- Those who have previously been diagnosed with IgA deficiency
- Those found unsuitable for undergoing the tests
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01524939
Start Date
January 1 2012
End Date
September 1 2012
Last Update
September 20 2012
Active Locations (7)
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1
Wonju christian Hospital
Wŏnju, Kang-won, South Korea, 220-701
2
Gachon University Gil Hospital
Incheon, South Korea
3
Asan Medical center
Seoul, South Korea
4
Kyung Hee university at Gangdong
Seoul, South Korea